Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee. Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers related to clinical responses. To assess PLA-695 exposure-response relationship on PD, efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.
This is a multi-center, randomized, double-blind, double-dummy, parallel, placebo- and positive-control (naproxen), dose-ranging study to assess the efficacy and safety of 3 oral doses of PLA-695 administered QD and 1 dose of PLA-695 administered BID for 6 weeks. Subjects will be randomized to 1 of 6 treatment groups: PLA-695 50 mg, 200 mg, or 400 mg QD, PLA-695 200 mg BID, placebo, or naproxen 500 mg BID. Subjects will undergo a washout period of 2 to 14 days. The number of days for washout will be determined by the pre-study NSAID of each subject. Subjects who washout from previous therapy with an increase in signs and symptoms of OA will be randomly assigned to receive PLA-695.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
560
WOMAC VAS walking pain (question 1) at week 6 is the primary endpoint.
WOMAC VAS walking pain at weeks 1, 2, 3, 4, and 5; WOMAC pain, stiffness, and function subscales, and composite score; Investigatorsâ Efficacy Evaluation; Investigatorsâ overall assessment; Joint tenderness. Subjectsâ Efficacy Evaluation.
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Huntsville, Alabama, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Palo Alto, California, United States
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Rancho Mirage, California, United States
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Upland, California, United States
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Delray Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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